What Is a Controlled Document Per ISO?
If your small business is in a highly regulated industry or if you have many specific policies and procedures, it’s important to follow the International Organization for Standards controlled document regulations. This is a process that oversees all documents related to your quality management system and ensures that they are under management control.
A controlled document by ISO standards is one that has been approved, revised and tracked to ensure quality.
The purpose of a controlled document per ISO standards is to ensure that all employees in the organization have access to the latest versions of the documents they need to do their job. When dealing with specific instructions or quality control measures, it’s vital that employees have access to the right information at the right time. Otherwise, they may make a critical error that comprises the quality of your products and services.
Controlled documents can refer to a number of different kinds of documents used within the organization, including quality manuals, procedures, work instructions and formats for records. They can be in hard copy or online or part of a document database. An important step to having a controlled document according to the ISO regulation is to have it approved when it is issued. The approving authority needs to stamp or sign the back of the document or the bottom of the document where the document identification is placed.
Approval needs to happen when the document is first issued and then two years after issue if the document has not been updated. If the document does not need to be updated after two years, then it can be marked as reapproved to indicate that it is still valid.
As per the ISO 9001 document review frequency guidelines, it’s important to ensure that all documents are up to date at all times to provide employees with the correct information. When a document is being revised, it’s critical to identify which document is the latest one so employees know which is the correct one to reference.
All pages in a document that have the same identification number need to be revised together. To note that the document has been revised, a number sequence can be added to the identification number — for example, "01" to indicate that it’s the first revision. Once the revision is complete, the approving authority needs to then reapprove the revision with a stamp or signature.
The controlled copy meaning also includes carefully tracking where documents are distributed or issued. This way, if a revision takes place or there is an issue with the controlled document, the company can track which employees or departments it needs to notify. For example, if a specific work instruction for the factory has recently been updated, the business can track to which employees that work instruction had been distributed. They can then contact those individuals to ensure they are aware of the update to the work instruction.
Sometimes, a controlled document needs to be taken out of circulation because it is outdated or obsolete. If that is the case, the obsolete document should be destroyed. If employees need to keep the obsolete document for a specific purpose, they need to clearly mark on the document that it is obsolete in red ink. This way, they can avoid any confusion with the outdated document.
For example, a human resources employee may receive a new form for employee health benefits and as a result will need to mark the old form obsolete. Instead of destroying the form, she may wish to keep it in case the company decides to go back to the old health benefits plan. As a result, she may find it more efficient to keep the old form for later use if needed. However, she will need to clearly indicate that the old form is obsolete.